On March 17, 2025, Monogram (NASDAQ:MGRM) announced that the FDA has granted 510(k) clearance for its Monogram mBôs TKA System. This determination means that the company can move forward with ...

EYSINS, Switzerland, April 3, 2025 /PRNewswire/ --Today, AliveDx announces it has submitted 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for the MosaiQ AiPlex ...

Companies must conduct robust risk-based assessments to determine whether modifications require a new 510(k) submission or other regulatory authorization. FDA’s guidance document, “Deciding ...

(RTTNews) - Daxor Corporation (DXR), Thursday announced the submission of its next-generation blood volume analyzer - Daxor BVA - to the Food and Drug Administration (FDA). The company says that ...

Fully Funded Through at least Fiscal 2026; Company Confirms No Material Impact from Global TariffsEDEN PRAIRIE, Minn., April 16, ...

On December 18, 2024, the Company announced the submission of its 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for review and clearance of its Intelligent ...

EYSINS, Switzerland, April 3, 2025 /PRNewswire/ -- Today, AliveDx announces it has submitted 510(k) premarket notification ... under review by the FDA, today's submission brings us a significant ...

EYSINS, Switzerland, April 3, 2025 /PRNewswire/ --Today, AliveDx announces it has submitted 510(k) premarket notification ... under review by the FDA, today's submission brings us a significant ...